TOE JOINT TITANIUM NPC M/L 21.5MM

GUDID M209168150

BIOPRO, INC.

Partial metatarsophalangeal joint prosthesis

• Primary Device ID: M209168150
• NIH Device Record Key: 88b93fa7-af8d-4d8d-9a88-fcd5ba7f68bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOE JOINT TITANIUM NPC M/L 21.5MM
• Version Model Number: 16815
• Company DUNS: 618749857
• Company Name: BIOPRO, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M209168150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041595

FDA Product Code

• KWD: Prosthesis, Toe, Hemi-, Phalangeal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-02-21
• Device Publish Date: 2015-09-16

On-Brand Devices [TOE JOINT TITANIUM NPC M/L 21.5MM]

• 00810012480109: 16815
• M209168150: 16815